The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: Letter
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Endo-Model Replacement Plateau; Item Number: 15-2836/11;. Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.. Classification: Class II. Quantity: 7 units (OUS only). Distribution: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
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